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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01093781 |
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Date of registration:
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24/03/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Aliskiren in Patients With Idiopathic Membranous Nephropathy
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Scientific title:
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A Pilot Study to Evaluate the Antiproteinuric Effect of Renin Inhibition With Aliskiren in Patients With Idiopathic Membranous Nephropathy |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT01093781 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Fernando Fervenza, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria
- Idiopathic MN proven by diagnostic kidney biopsy.
- Age =18 years but = 80 years.
- Proteinuria as measured by urinary protein/urinary creatinine > 4.0 on a spot sample
aliquot from a 24-hour urine collection.
- Estimated GFR = 30 ml/min/1.73m^2 using the 4 variable Modification of Diet in Renal
Disease (MDRD) equation.
Exclusion Criteria
- Age <18 years.
- Estimated Glomerular Filtration Rate (GFR) < 30 ml/min/1.73m^2, or serum creatinine
>3.0 mg/dl.
- Patient must be off prednisone, calcineurin inhibitor or mycophenolate mofetil for >
1 month and alkylating agents for > 6 months.
- Patients with presence of active infection or a secondary cause of MN (e.g. hepatitis
B, HIV, systemic lupus erythematosus (SLE), medications, malignancies).
- Type 1 or 2 diabetes mellitus. Patients who have recent history of steroid induced
diabetes but no evidence of diabetic nephropathy on renal biopsy performed within 6
months of entry into the study are eligible for enrollment.
- Pregnancy or nursing for safety reasons.
- Acute renal vein thrombosis documented prior to entry by renal US or CT scan.
- Previous therapy with Aliskiren
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Idiopathic Membranous Nephropathy
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Intervention(s)
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Drug: Aliskiren
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Primary Outcome(s)
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Urine protein excretion
[Time Frame: one year]
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Secondary Outcome(s)
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Blood pressure control; tolerability and side effects
[Time Frame: one year]
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Secondary ID(s)
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09-007837
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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